This document provides an overview of the clinical research process. It discusses what research is, the purposes of research, and the typical steps involved. These steps include prioritizing a research topic, reviewing existing literature, developing a proposal, obtaining approval, collecting and analyzing data, writing reports, and presenting results. The document also covers generating research questions using techniques like critical thinking and observation. It introduces frameworks for formulating good research questions, including PICO/PECO for structuring questions and FINER for testing question feasibility. Finally, it discusses formulating hypotheses for the research.

1. 1
Clinical Research Basics
Mohamed Fahmy Doheim
M.B.B.Ch Candidate

2. Science Vs.
Pseudoscience!

3. What is research?
• Systematic investigation to
establish facts or principles or to
collect information on a subject.
• Research is the systematic
collection, analysis and interpretation
of data to answer a certain question
or solve a problem.

4. Research, why?

5. Citable documents in
Medicine

6. Purposes of research
• Exploration
• Description
• Explanation

7. 7
What are the Steps?
• Prioritizing and selecting a research topic (Idea, question)
• Review of literature and other existing information
• Development of a research proposal
• Getting formal institutional approval
• Data collection (field work)
• Data processing and analysis
• Final report writing
• Presenting the results in Scientific publications,
presentation at meetings…etc.

8. 8
What are the Steps?
• Prioritizing and selecting a research topic (Idea, question)
• Review of literature and other existing information
• Development of a research proposal
• Getting formal institutional approval
• Data collection (field work)
• Data processing and analysis
• Final report writing
• Presenting the results in Scientific publications,
presentation at meetings…etc.

9. Topics of the series
• Research question or idea: generating and
formulating
• Medical literature : What, where and how?
• Study designs and pyramid of evidence.
• Medical statistics
• How to read a paper?
• How to write a paper?
• Publication process

10. !Let’s start
Formulation of
Research Question

11. Our Aim
Good Idea
Answerable research
question

12. Research idea
• Research idea provides the very
basic foundation of research work
• Good idea ---- good research

13. 1- Picking up the
research idea
A) Reading literature
B) Clinical practice and observation

14. A) Reading literature:
• When we read the literature, we usually will find
some gaps and questions that need to be
answered and some results that need to be
confirmed.
• That's usually will come from the discussion part
and the "recommendations" which the authors
have proposed for further research.
• Here, the most important thing u will need is
caring reading and critical thinking to
generate your question.

15. Critical thinking
17+18 (is/are) 26?
IS or ARE?

16. B) Clinical practice and
observation:
• During clinical practice, you may find a case or
cases admitted with some manifestations and
passed many stages to reach the diagnosis and u
may report as it is not classical (Case report or
series).
• Moreover, you may observe something and
generate and test your hypothesis (Finding a
correlation)

17. Useful Techniques
• Rational thinking
• Creative thinking
• Searching the literature
• Scanning the media
• Brainstorming
• Exploring past projects
• Discussion
• Keeping an ideas notebook

18. Ranking of research topics
Rating Sheet For Group Work
Total
Criteria for selection of research topic
Proposed
topic
Ethical
acceptability
Urgency
of data
needed
ApplicabilityPolitical
acceptability
FeasibilityAvoidance
of
duplication
Relevance
1.
2.
3.
4.
5.
Rating scale: 1 = low, 2 = medium, 3 = high.

19. 2-Formulating your
question
PICO
Principle

20. PICO
• Population, Patient, Problem P
• Intervention or Indicator I
• Comparator or Control C
• Outcome O

21. PECO
• Population, Patient, Problem P
• Exposure E
• Comparator or Control C
• Outcome O

22. PICO Example
In mild to moderate adult asthmatics
(P), does the regular use of salbutamol
(I) compared to as needed use (C)
result in worse asthma control (O)

23. Testing your question
FINER method

24. FINER
• Feasible: adequate subject, expertise, affordable
• Interesting: to the investigator
• Novel: confirm, extend or refute previous
findings and provide new findings
• Ethical: fulfill guidelines for the protection
• Relevant: to scientific knowledge

25. Broad or narrow?
Research question could be broad,
intermediate or narrow question:
• Broad: Efficacy of treatments of spinal muscular atrophy.
• Intermediate: Efficacy of VPA for spinal muscular atrophy.
• Narrow: Efficacy of VPA for spinal muscular atrophy type 2.

26. Formulating a hypothesis
• Adopted by the researcher is referred
to as (Alternative Hypothesis;
H1)
• The opposite event is referred to as
(Null hypothesis; H0).
• Directional or not?